The Potential of Carnosine Supplementation in Reducing the Cardiometabolic Risk

What Was Tested

The trial (not phased) is built around Carnosine.

It had two arms (groups): Intervention (active comparator) and Control (placebo comparator).

The registry classes the interventions as dietary supplement and other.

More on the Plan

Cardiovascular risk factors including type 2 diabetes underpin a major threat to the globe and result in a heavy health and financial burden across the healthcare system.

Treating type 2 diabetes and cardiovascular disease is expensive and often unsatisfactory.

As a further concern, the micro- and macrovascular complications of type 2 diabetes often start developing before actual diagnosis.

Could carnosine be that alternative?

Who Took Part

The registry lists 84 planned participants were the target.

It was open to people of any sex aged from 18 years up to 60 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Age \>18 or \<60 years,. Weight change \< 5 kg in last 12 months. BMI \>25kg/m2 but weight \<159kg due to DEXA scan restrictions. Non-diabetic, no allergy, non-smoker, no high alcohol use. No current intake of medications including vitamin supplements.

The full record lists 7 inclusion and 7 exclusion criteria; among the exclusions: age \<18 or \> 60 years; weight change \> 5 kg in last 12 months; diabetes (diagnosed or oral glucose tolerance test (ogtt), allergy.

How the Study Was Run

It was run as a randomized, parallel-group and quadruple-blind study.

The participants were allocated by chance, so the Carnosine group and the comparison group should start out alike.

The Carnosine group and the comparison group ran side by side rather than switching.

Neither the participants nor the staff measuring them knew who was on Carnosine, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2017-02-13 with completion listed for 2020-02-13.

It ran at 1 site in Australia.

Its stated primary purpose is prevention.

What Was Measured

Primary outcome: Change in insulin sensitivity measured by euglycaemic glucose clamp (time frame: From baseline to 14 weeks).

It also tracked 3 secondary outcomes, for example Change in markers of endothelial dysfunction, Change in Acute Insulin Secretory Response - Intravenous Glucose Tolerance Test and Change in Resting systolic and diastolic blood pressure.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Carnosine in 84 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Carnosine compound page, all human trials.